Workplace Material Safety Data Sheet
Common/Trade
name
Synonyms
Chemical name
CI#
Chemical formula
Chemical family
Material uses
DSL#
CAS#
Code
Molecular weight
Apo-Tramadol HCl Tablets 50 mg
Tramadol Hydrochloride Tablets
Brand Name: Ultram
Not applicable.
Not applicable.
Not available.
Not on the DSCL list.
Not applicable.
42617
Not applicable.
Pharmaceutical industry: Dosage form
Therapeutic category: analgesic.
TRAMADOL25125
WHMIS
Protective Clothing
TDG Air/Road/Rail
Section 1. Product Identification and Uses
Manufacturer
Apotex Inc.
50 Steinway Blvd
Etobicoke, Ontario
Canada M9W 6Y3
Tel. (416) 675-0338
Supplier
TorPharm
Etobicoke, Ontario
M9W 6Y3
Canada
Tel. (416) 675-0338
APOTEX INC.
Emergency phone
(416)-749-9300 ext. 5555
For general information call ext. 8483 (8 AM-4 PM)
DIN
Not available.
Chemical
structure
Not applicable.
Not regulated under WHMIS: Covered by Food &
Drug Act.
Canadian Classifications
1
0
2
NFPA
2
Apotex
Haz. Class
Not expected to be hazardous under normal handling conditions.
Possible hypersensitization.
Section 2. Hazards Identification
Potential Acute Health
Effects
Potential Chronic Health
Effects
Not regulated under WHMIS: Covered by Food & Drug Act.
Remark
CLASS D-2B: Material causing other toxic effects (TOXIC).
WHMIS
Eye contact
Skin contact
Slight inhalation
Flush with copious quantities of water. If irritation persists, obtain medical advice.
Not expected to result in hazardous effects.
Flush with copious amounts of water. Seek medical attention if irritation persist.
Not expected to result in hazardous effects.
Section 3. First Aid Measures
Hazardous skin
contact
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Apo-Tramadol HCl Tablets 50 mg
Not expected to be hazardous. It is good practice to rinse mouth thoroughly with water and drink a cup of water to
minimize discomfort.
Hazardous
inhalation
Slight ingestion
Hazardous ingestion
Remove from exposure. Persons developing serious hypersensitivity reactions must receive immediate medical
attention. If not breathing give artificial respiration (use protective mask with one-way valve). If breathing is difficult give
oxygen.
Never give anything by mouth if victim is rapidly losing consciousness, or is unconscious or convulsing. Rinse mouth
thoroughly with water. If breathing has stopped, trained personnel should begin artificial respiration (use protective
mask with one-way valve), or if the heart has stopped, cardiopulmonary resuscitation (CPR) immediately. Seek medical
attention.
Overdosage: Serious potential consequences of overdosage are respiratory depression and seizure. In treating an
overdose, primary attention should be given to maintaining adequate ventilation along with general supportive
treatment. While naloxone will reverse some, but not all, symptoms caused by overdosage with Tramadol the risk of
seizures is also increased with naloxone administration. In animals convulsions following the administration of toxic
doses of tramadol could be suppressed with barbiturates or benzodiazepines but were increased with naloxone.
Naloxone administration did not change the lethality of an overdose in mice. Hemodialysis is not expected to be helpful
in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.
Tramadol hydrochloride
73806-49-2
50
Tramadol:
TDLo: 16 mg/kg/4D (intermittent-woman)
LD50: 228 mg/kg (oral-rat)
Toxicity values of the hazardous ingredients
Section 4. Composition and Information on Ingredients
Name
CAS #
% (w/w)
TLV
Not available.
The product is:
Autoignition
temperature
Fire degradation
products
Flash points
Fire extinguishing
procedures
Flammable limits
Flammability
Not available.
Combustible.
These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...).
Not available.
Not available.
Extinguisher media: water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and
materials.
Special fire fighting procedures: As with all fires, evacuate personnel to safe area. Firefighters should use
self-contained breathing equipment and protective clothing.
Not available
No additional remark.
Remark
Risks of explosion
Risks of explosion of the product in presence of mechanical impact: No.
Risks of explosion of the product in presence of static discharge: Not available.
Remark
No additional remark.
Section 5. Fire Fighting Measures
Small spill and leak
Large spill and leak
Vacuum or sweep up spillage. Avoid dust. Place spillage in appropriate labeled solid pharmaceutical waste class
261A container for waste disposal. Wash contaminated clothing before reuse. Ventilate area and wash spill site.
Follow appropriate Safe Work Practice.
Use a shovel to put the material into a appropriate labeled waste disposal container. Finish cleaning by
spreading water on the contaminated surface. Label and dispose as pharmaceutical waste class 261A. Follow
appropriate Safe Work Practices.
Section 6. Accidental Release Measures
Protective Clothing Pictograms in case of large spill and/or high exposure levels
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Apo-Tramadol HCl Tablets 50 mg
Protective clothing in
case of large spill
Covering uniform. Gloves.
Storage
Precautions
Section 7. Handling and Storage
In case of insufficient ventilation, wear suitable respiratory equipment. Avoid breathing dust. Wash thoroughly
after handling. Dispose of as pharmaceutical waste Class 261A.
Store at room temperature (15-30°C) , in a dry place, out of direct sunlight, in a tightly closed container.
Engineering Controls
Personal Protection
Exposure to this material can be controlled in many ways. The measures appropriate for a particular worksite
depend on how this material is used and on the extent of exposure. This general information can be used to
help develop specific control measures. Ensure that control systems are properly designed and maintained.
Comply with occupational, environmental, fire, and other applicable regulations.
Engineering methods to control hazardous conditions are preferred. Methods include mechanical (local exhaust)
ventilation, process or personnel enclosure and control of process conditions. Administrative controls and
personal protective equipment may also be required. Supply sufficient replacement air to make up for air
removed by exhaust system.
Exposure Limits
Section 8. Exposure Controls/Personal Protection
Protective Clothing
(Pictograms)
Covering uniform. Gloves.
Not available.
PERSONAL PROTECTIVE EQUIPMENT :
Under normal work conditions, the use of personal protective equipment is not expected to be required.
However major spills should require the use of designated personal protective equipment. If engineering
controls and work practices are not effective in controlling exposure to this material, then wear suitable personal
protective equipment including approved respiratory protection. Have appropriate equipment available for use in
emergencies such as spills or fire.
If the physical state of the finished product is altered by crushing, grinding or breakage, appropriate PPE may
be required including dust respirator.
Refer to the CSA Standard Z94.4-M1982, "Selection, Care, and Use of Respirators," available from the
Canadian Standards Association, Rexdale, Ontario, M9W 1R3.
RESPIRATORY PROTECTION GUIDELINES :
Under normal work conditions, the use of personal protective equipment is not expected to be required.
However major spills should require the use of designated personal protective equipment.
EYE/FACE PROTECTION : Not required under normal working conditions.
SKIN PROTECTION : The use of gloves is required for Good Manufacturing Practices (GMP) compliance.
RESISTANCE OF MATERIALS FOR PROTECTIVE CLOTHING :
Guidelines : GOOD: Natural, butyl or styrene-butadiene rubber (SBR), neoprene, nitrile, polyvinyl chloride
(PVC), polyurethane, nitrile+PVC, neoprene+SBR, neoprene+natural rubber, SBR/neoprene NOTE: Resistance
of specific materials can vary from product to product. Evaluate resistance under conditions of use and maintain
clothing carefully.
EXPOSURE CONTROLS/PERSONAL PROTECTION COMMENTS :
Remove contaminated clothing promptly. Launder before rewearing. Inform laundry personnel of contaminant's
hazards. Do not eat, drink or smoke in work areas. Wash hands thoroughly after handling this material. Maintain
good housekeeping.
Section 9. Physical and Chemical Properties
Physical state and
appearance
Volatility
pH (1% soln/water)
Odor
Color
Taste
Odor threshold
Solid. (Film-coated, capsule-shaped tablets)
Not applicable.
Not available.
White.
Not available.
Not available.
Not available.
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Apo-Tramadol HCl Tablets 50 mg
Melting point/
Freezing point
Boiling point
Vapor pressure
Specific gravity
Vapor density
Water/oil dist. coeff.
Ionicity (surface active
agent)
Dispersion properties
Solubility
Not available.
Not available.
Not available.
Not available.
Not available.
Not available.
Not available.
Soluble in water.
Critical temperature
Not available.
Instability temperature Not available.
Conditions of instability Not available.
Evaporation rate
See solubility.
Not applicable.
Hazardous decomp.
products
Stability
Corrosivity
Reactivity/
Incompatibility
Remark
Degradability
Remark
Normally stable.
Not available.
Not corrosive
Not available.
No additional remark.
No additional remark.
Not available.
Section 10. Stability and Reactivity
Toxicity data
Remark
Routes of entry
Long-term effects
As the product is a solid dosage form, the major route of entry is ingestion. Other routes of entry, including
inhalation, skin and eye contact may occur only under certain circumstances.
Tramadol:
RTECS#: GV8925000
TDLo: 16 mg/kg/4D (intermittent-woman)
LD50: 228 mg/kg (oral-rat)
Target organ: Centaral nervous system
Possible hypersensitization.
Carcinogenicity: A slight, but statistically significant, increase in two common murine tumors, pulmonary and
hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice (dosing orally up to 30 mg/kg for
approximately two years, although the study was not done with the Maximum Tolerated Dose). This finding is not
believed to suggest risk in humans. No such finding occurred in a rat carcinogenicity study.
Reproductive Toxicity: No effects on fertility were observed for tramadol at oral dose levels up to 50 mg/kg in male
rats and 75 mg/kg in female rats.
Teratogenicity: There are no adequate and well-controlled studies in pregnant women. Tramadol should be used
during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pragnancy category C.
Tramadol has been shown to be embryotoxic and fetotoxic in mice, rats and rabbits at maternally toxic doses 3 to
15 times the maximum human dose or higher (120 mg/kg in mice, 25 mg/kg or higher in rats and 75 mg/kg or
higher in rabbits), but was not teratogenic at these dose levels. No harm to the fetus due to tramadol was seen at
The toxicological properties have not been thoroughly investigated.
Section 11. Toxicological Information
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Apo-Tramadol HCl Tablets 50 mg
Short-term effects and
Signs & Symptoms of
overexposure
Remark
Remark
Possible eye, skin, gastrointestinal and/or respiratory tract irritation.
Dosage: Tramadol should be started at 25 mg/day qAM and titrated in 25 mg increments as separate doses every
3 days to reach 100 mg/day (25 mg q.i.d.). Thereafter the total daily dose may be increased by 50 mg as tolerated
every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, Tramadol 50 to 100 mg can be administered as
needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.
The most frequently reported adverse reactions were in the central nervous system and gastrointestinal system.
A variety of other adverse events were reported infrequently in patients taking tramadol during clinical trials:
Coordination disturbance; Paresthesia; Cognitive dysfunction; Euphoria; Nervousness; Sleep disorder
Hallucinations; Tremor; Amnesia; Difficulty in concentration; Abnormal gait Gastrointestinal Abdominal pain;
Anorexia; Flatulence Musculoskeletal Hypertonia Respiratory Dyspnea Skin Rash Urticaria, Vesicles Special
Senses Visual disturbance Dysgeusia Urogenital Urinary retention; Dysuria; Menstrual disorder Urinary frequency;
Menopausal symptoms. A causal relationship between tramadol and these events has not been determined.
However, the most significant events are listed below as alerting information to the physician: Body as a whole:
Suicidal tendency.
Cardiovascular: Abnormal ECG, hypertension, myocardial ischemia, palpitations.
Central Nervous System: Migraine.
Gastrointestinal: Gastrointestinal bleeding, hepatitis, stomatitis.
Laboratory abnormalities: Creatinine increase, elevated liver enzymes, hemoglobin decrease, proteinuria.
Sensory: Cataracts, deafness, tinnitus.
Overdose: Cases of overdose with tramadol have been reported. Estimates of ingested dose in foreign fatalities
have been in the range of 3 to 5 g. A 3 g intentional overdose by a patient in the clinical studies produced emesis
and no sequelae. The lowest dose reported to be associated with fatality was possibly between 500 and 1000 mg
in a 40 kg woman, but details of the case are not completely known.
doses that were not maternally toxic.
Mutagenicity: Tramadol was not mutagenic in the following assays: Ames Salmonella microsomal activation test,
CHO/HPRT mammalian cell assay, mouse lymphoma assay (in the absence of metabolic activation), dominant
lethal mutation tests in mice, chromosome aberration test in Chinese hamsters, and bone marrow micronucleus
tests in mice and Chinese hamsters. Weakly mutagenic results occurred in the presence of metabolic activation in
the mouse lymphoma assay and micronucleus test in rats. Overall, the weight of evidence from these tests
indicates that tramadol does not pose a genotoxic risk to humans.
The above adverse effects are based on clinical studies.
Medical conditions aggravated by exposure: Hypersensitivity to material, in cases of acute intoxication with
alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
Section 12. Ecological Information
Ecotoxicity
Not available.
BOD5 and COD5
Products of
Biodegradation
Toxicity of the Products
of Biodegradation
Special Remarks on the
Products of
Biodegradation
Not available.
Possibly hazardous short term degradation products are not likely. However, long term degradation products may
arise.
The products of degradation are less toxic than the product itself.
No additional remark.
Section 13. Disposal Considerations
Waste Disposal
Collect in sealed containers and place in appropriate labeled pharmaceutical solid waste class 261A container
according to internal and external standards and procedures. Follow all appropriate safe work procedures and
federal, provincial and local regulations for disposal. Use only licensed disposal and waste hauling companies.
Section 14. Transport Information TDG, IATA, IMDG
Not controlled under TDG (Canada).
UN
Not applicable (PIN and PG).
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Apo-Tramadol HCl Tablets 50 mg
Special Provisions for
Transport
Not applicable.
Section 15. Other Regulatory Information and Pictograms
0
1
2
This product is not classified according to the EU regulations.
USA Classifications
HCS (Hazardous Communication System)
(OHSA, U.S.A.)
DSCL Risk (R)
and Safety (S) Phrases
Hazardous Material
Information System
(U.S.A.)
National Fire
Protection
Association (U.S.A.)
Health
Fire Hazard
Reactivity
Specific Hazard
DOT (Department of
Transportation)
(U.S.A) (Pictograms)
DSCL (Dangerous
Substances
Classifications)
(Europe) (Pictograms)
ADR (European
Agreement
of Dangerous goods by
Road)
(Pictograms)
**NATIONAL FIRE PROTECTION ASSOCIATION (NFPA) HAZARD INDEX**
NFPA-HEALTH-blue :2-Hazardous to health.
NFPA-FLAMMABILITY-red :1-Materials that must be preheated before ignition can occur.
NFPA-REACTIVITY-yellow :0-Normally stable.
Not an HCS controlled material in USA.
European Classifications
Other Regulations
Not available.
Not controlled under ADR (Europe).
Not a DOT controlled material (United States).
Personal Protection
Reactivity
Fire Hazard
Health Hazard
2
* - Chronic hazard indicator
X - See Section 8
1
0
X
Section 16. Other Information
Validation date:
(year.month)
References
The Merck Index, twelfth edition
HSBD & RTECS Database
RxList Monographs
Physicians Desk Reference
MSDS:
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Apo-Tramadol HCl Tablets 50 mg
Validated on 11/04/2005.
Printed 11/04/2005.
Apotex Inc.
150 Signet Drive
Weston (Toronto), Ontario
Canada M9L 1T9
(416) 749-9300
Other Special
Considerations
SAMPLING AND ANALYSIS :
Use appropriate instrumentation and sampling strategy (location, timing, duration, frequency, and number of samples).
Interpretation of the sampling results is related to these variables and the analytical method. OSHA method IMISC136 has
been published, but is not validated.
Notice to Reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named supplier nor any of its subsidiaries assumes any
liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any material is the sole
responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot
guarantee that these are the only hazards that exist.